After completion of this course, attendees will have enhanced knowledge of the ever-changing landscape of Medical Device Regulation in the EU, Also The content of this course is designed to simplify the understanding of requirements and to provide attendees with the latest insight on how changes are being viewed and implemented by companies marketing products in the EU.

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Overview:

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU.

It includes specific insights from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Areas of change between the prior Medical Device Directive (MDD) and the MDR will be discussed as well as expectations for how to implement ISO-13485:2016.

Learning Objective:

Upon completion of this course, attendees will have enhanced knowledge of the ever-changing landscape of Medical Device Regulation in the EU

The content of this course is designed to simplify the understanding of requirements and to provide attendees with the latest insight on how changes are being viewed and implemented by companies marketing products in the EU

Course Agenda:

EU Regulatory and Legislative Structure

EU Definition of a Medical Device

3 EU Directives -> 2 EU Regulations

Key Agencies Involved

Why the change from Directives to Regulations?

Overview of CE Marking Process & Changes Resulting from the EU MDR

Updated Role of the Notified Body

Medical Device Classifications

Essential Requirements -> Safety & Performance Requirements

Integration of Risk Assessment / Risk Management

Conformity assessment

Device Vigilance & Reporting System

MDR Overview (by Article & Annex)

ISO 13485:2016 Updates

Medical Device Single Audit Program (MDSAP)

Global Impact of ISO 13485:2016 Certification and CE Marking

Tips on Working with Regulatory Authorities

Who Will Benefit:

Executive Management

Quality Assurance

Regulatory Affairs

Clinical Research and Medical Operations

Product Development

Manufacturing / Distribution

Medical Device R&D

Clinical Trial Supply

CRO's

Speaker Profile

Robert J. Russell is a Global Regulatory and CMC expert with 28 years of prior industry experience in international regulatory management and compliance, global business development and global supply chain management. Mr. Russell formerly held senior leadership positions, in these functional areas, at Dow Pharmaceuticals and Cordis-Dow Medical Devices.

His experience and knowledge span Healthcare Authority's requirements and regulatory processes across Life Science products.
For the past 18 years, Bob has been President & CEO of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding Regulations affecting compliance and in conducting product registrations with their clients in more than 95 countries.
He holds a BS / MS in Chemistry."